Hutchison China MediTech (Chi-Med) Reports 2017 Interim Results And Updates Shareholders On Key Clinical Programs
Published: Jul 31, 2017
LONDON--(BUSINESS WIRE)--Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM), the China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market, today announces its unaudited financial results for the six months ended June 30, 2017.
“Use of Non-GAAP Financial Measures and Reconciliation”
Group: Record revenue; continued investment in clinical pipeline
- Group revenue up 21% to $126.6 million (H1 2016: $104.5m).
- Net income attributable to Chi-Med of $1.7 million (H1 2016: $0.5m), including $37.5 million in research and development expenses on an as adjusted basis (H1 2016: $36.0m).
Innovation Platform: Submitted first China New Drug Application (“NDA”) on fruquintinib; initiated first global Phase III registration study on savolitinib; five other pivotal Phase III studies underway or completing; three more preparing to start
Deep clinical pipeline of novel small molecule tyrosine kinase
- Eight clinical drug candidates now in 31 active or completing clinical trials (H1 2016: 25) around the world; over 3,100 subjects dosed in our trials to date, with over 300 dosed in the first half of 2017.
Fruquintinib – Highly selective TKI of vascular endothelial growth
factor receptor (“VEGFR”)-1/2/3:
- Positive outcome in Phase III study, the FRESCO study, in third-line colorectal cancer (“CRC”) patients in China;
- Potentially best-in-class in terms of both efficacy and safety relative to Stivarga® (regorafenib);
- 2017 American Society of Clinical Oncology (“ASCO”) oral presentation;
- NDA submitted in third-line CRC to the Center for Drug Evaluation of the China Food and Drug Administration (“CFDA”).
Savolitinib – Highly selective TKI of the mesenchymal epithelial
transition factor (“c-MET”):
- Presented positive Phase II data in c-MET-driven papillary renal cell carcinoma (“PRCC”) at the ASCO Genitourinary Cancers Symposium;
- Initiated global Phase III study, the SAVOIR study, in c-MET-driven PRCC in a head-to-head comparison with current standard therapy Sutent® (sunitinib). The first Phase III study ever conducted with molecularly selected patients in renal cell carcinoma;
- Initiated a global epidemiology study in c-MET-driven PRCC to demonstrate the importance of treatment with a c-MET inhibitor.
Presented positive proof-of-concept data on:
- Fruquintinib in gastric cancer in combination with Taxol® (paclitaxel);
- Sulfatinib in neuroendocrine tumors (“NET”) as well as preliminary data in thyroid cancer.
Progressing multiple Phase I dose escalation studies in Australia
and China on:
- HMPL-523 against spleen tyrosine kinase (“Syk”);
- HMPL-453 against fibroblast growth factor receptor 1/2/3 (“FGFR”);
- HMPL-689 against phosphoinositide 3-kinase delta (“PI3Kd”);
- Theliatinib against epidermal growth factor receptor (“EGFR”) wild-type;
- Expect to complete dose escalation and initiate proof-of-concept expansion trials on these drug candidates towards end of 2017 or early 2018.
Commercial Platform: High-performance drug marketing and distribution platform covers ~300 cities/towns in China with >3,300 sales people. High value products and household name brands